9. Certifications
Device standard: This medical device is manufactured to meet the re-
quirements European and United States standards for
non-invasive blood pressure monitors
EN1060–1 / 12:95
EN1060–3 / 09:97
DIN 58130, NIBP – clinical investigation
ANSI / AAMI SP10, NIBP - requirements
Electromagnetic compatibility: Device fulfils the stipulations of the European stan-
dard EN 60601–1–2
Clinical testing: Clinical performance tests were carried out in the
U.S. and Germany according to the DIN 58130/1997
procedure N6 (sequential) and AAMI. (U.S.)
The stipulations of the EU-Guidelines 93/42/EWG for Medical Products Class IIa have been fulfilled.
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